BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FLASH Flex™ Aorto-Ostial Angioplasty System

    K Number: K254022 · Decision Apr 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    85
    Applicant Total
    2
    Review Days
    107

    Basic Information

    Device Name
    FLASH Flex™ Aorto-Ostial Angioplasty System
    K Number
    K254022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Verge Medical, Inc.
    Date Received
    December 16, 2025
    Decision Date
    April 2, 2026
    Product Code
    LOX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

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